A scintigraphic study to investigate Aspirin and Ibuprofen tablets

• Research type

  Research Study

• Full title

  An open label, randomized, four-way crossover trial to assess the disintegration, gastric emptying and pharmacokinetic parameters of a new disintegrating acetylsalicylic acid 500 mg, 1000 mg tablet formulation, the standard acetylsalicylic acid 500 mg tablet and standard 400 mg ibuprofen tablet in fasted healthy male subjects

• IRAS ID

  214822

• Contact name

  Howard N.E. Stevens

• Contact email

  howard.stevens@bddpharma.com

• Sponsor organisation

  Bayer Consumer Care AG

• Eudract number

  2016-004546-29

• Duration of Study in the UK

  0 years, 2 months, 24 days

• Research summary

  This study will investigate the performance of a new disintegrating tablet containing 500 mg acetylsalicylic acid (commonly known as Aspirin).

  The new disintegrating tablet has shown faster dissolution in vitro (outside the body). In this study we will intend to understand the disintegrating behaviour inside the body (in vivo).

  The study will compare the new disintegrating tablet against three other formulations: a new disintegrating Aspirin tablet containing 1000 mg acetylsalicylic acid; a standard Aspirin tablet containing 500 mg acetylsalicylic acid and a standard Ibuprofen tablet containing 400 mg Ibuprofen.

  Up to 12 healthy male volunteers will participate in this study, each receiving the following treatments in a randomised order:
  · 1 x 500 mg disintegrating Aspirin tablet
  · 1 x 1000 mg disintegrating Aspirin tablet
  · 1 x 500 mg standard Aspirin tablet
  · 1 x 400 mg standard Ibuprofen tablet

  We will be looking to:
  · assess site and time to complete tablet disintegration of the new disintegrating Aspirin 500 mg compared with the standard Aspirin 500 mg tablet.
  · assess site and time to complete tablet disintegration of the new disintegrating Aspirin 1000 mg tablet formulation and a standard 400 mg ibuprofen tablet;
  · assess gastric emptying kinetics of the four radiolabelled formulations;
  · assess site and time of onset of tablet disintegration of the four formulations;
  · assess further parameters derived from the scintigraphy analysis of the four
  formulations;
  · assess further pharmacokinetic parameters for Acetylsalicylic acid, salicylic acid and ibuprofen total

  To look at these parameters we will add a small amount of radioactive material to the four tablets. The radiation emitted will then be detected by taking images using a gamma camera. We will also take blood samples, allowing us to measure the levels of each drug in the subjects' bloodstream.

• REC name

  Scotland A: Adults with Incapacity only

• REC reference

  17/SS/0017

• Date of REC Opinion

  6 Mar 2017

• REC opinion

  Favourable Opinion